SAC-CEL
FDA 510(k) clearance K813508 · decided 1981-12-29
Clearance details
- K-number
- K813508
- Device name
- SAC-CEL
- Applicant
- Burroughs Wellcome Co.
- Decision
- Substantially Equivalent
- Date received
- 1981-12-15
- Decision date
- 1981-12-29
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- KTS
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CENTRIA RADIOIMMUNOASSAY SEPARATION (K792636) | Union Carbide Corp. | 1980-01-11 |
| CENTRIA-SET TYPE D(ANTI-SHEEP/GOAT) (K792637) | Union Carbide Corp. | 1980-01-11 |
| SECOND ANTIBODY (K781070) | Pcl-Ria, Inc. | 1978-08-10 |
Recalls involving this device
No recalls on record reference this clearance.